This medication is used to prevent pregnancy. It is a thin plastic rod about the size of a matchstick that is inserted under the skin by a health care professional. The rod slowly releases etonogestrel into the body over a 3-year period. The rod must be removed after 3 years and can be replaced if continued birth control is desired. The rod can be removed at any time by a trained health care professional if birth control is no longer desired or there are side effects. It does not contain any estrogen. Etonogestrel (a form of progestin) is a hormone that prevents pregnancy by preventing the release of an egg (ovulation) and by changing the womb and cervical mucus to make it more difficult for an egg to meet sperm (fertilization) or for the fertilized egg to attach to the wall of the womb (implantation).
Read the Patient Information Leaflet provided by your pharmacist or health care provider before the rod is placed. Read and sign the Informed Consent provided by your doctor. You will also be given a User Card with the date and the place on your body where the rod was inserted. Keep the card and use it to remind yourself when to schedule an appointment to have the rod removed. If you have any questions, ask your doctor or pharmacist.
Ask your doctor about the best time to schedule your appointment to have the rod placed. Your doctor may want you to have a pregnancy test first. The medication usually starts working right away when the rod is inserted on days 1 through 5 after the start of your regular menstrual bleeding. If your appointment is at another time in your menstrual cycle, you may need to use a non-hormonal form of birth control (e.g., condoms, diaphragm, spermicide) for the first 7 days after the rod is placed. Ask your doctor about whether you need back-up birth control.
The rod will be inserted into the skin in your upper arm. Usually it will be placed in the arm opposite the side you write with. Be sure you can feel the rod underneath your skin after it has been placed.
There will be 2 bandages covering the area where the rod is placed. Leave the top bandage on for 24 hours. Keep the smaller bandage on for 3-5 days or as directed by your doctor. Keep the bandage clean and dry.
Nausea, stomach cramping/bloating, dizziness, headache, breast tenderness, acne, hair loss, weight gain, and vaginal irritation/discharge may occur. Pain, bruising, numbness, infection, and scarring may occur at the site where the rod is placed. If any of these effects persist or worsen, notify your doctor promptly.
Your periods may be early or late, shorter or longer, heavier or lighter than normal. You may also have some spotting between periods, especially during the first several months of use. If bleeding is prolonged (more than 8 days) or unusually heavy, contact your doctor. If you miss 2 periods in a row, contact your doctor for a pregnancy test.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
The rod must be removed after 3 years. This is usually a simple procedure done in your doctor's office. Rarely (e.g., if the rod has been placed too deeply or can't be felt), the rod may require surgery to remove.
This medication may rarely cause serious (sometimes fatal) problems from blood clots (e.g., pulmonary embolism, stroke, heart attack). Seek immediate medical attention if you experience: sudden shortness of breath, chest/jaw/left arm pain, confusion, coughing up blood, sudden dizziness/fainting, pain/swelling/warmth in the groin/calf, tingling/weakness/numbness in the arms/legs, headaches that are different from those you may have experienced in the past (e.g., headaches with other symptoms such as vision changes/lack of coordination, existing migraines becoming worse, sudden/very severe headaches), slurred speech, weakness on one side of the body, vision problems/changes.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before having the rod placed, tell your doctor or pharmacist if you are allergic to etonogestrel; or to other progestins; or to any anesthetics or antiseptics that might be used in the procedure; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: abnormal breast exam, blood clots (e.g., in the legs, eyes, lungs), breast cancer, depression, high blood pressure, low levels of "good" cholesterol (HDL), diabetes, gall bladder disease, heart disease (e.g., chest pain, heart attack), history of yellowing eyes/skin (jaundice) during pregnancy or while using birth control pills, liver problems (e.g., liver tumor, active liver disease), migraine headaches, seizures, stroke, long periods of sitting or lying down (e.g., immobility such as being bedridden), unexplained vaginal bleeding.
Smoking cigarettes/using tobacco while using hormonal birth control (implant/pill/patch/ring) increases your risk of heart problems and stroke. Do not smoke. The risk of heart problems increases with age (especially in women over 35) and with frequent smoking (15 or more cigarettes a day).
Notify your doctor at least 4 weeks beforehand if you will be having surgery or will be confined to a chair/bed for a long time (e.g., a long plane flight). You may need to have this medication removed temporarily or take special precautions at these times while you are using this drug.
The drug in this implant may cause blotchy, dark areas on your skin (melasma). Sunlight may intensify this effect. If this occurs, avoid prolonged sun exposure, use a sunscreen, and wear protective clothing when outdoors.
If you are nearsighted or wear contact lenses, you may develop vision problems or may have problems wearing your contact lenses. Contact your eye doctor if these problems occur.
This product should not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. A certain serious pregnancy problem (ectopic pregnancy) may be more likely if you become pregnant while using this product.
This medication passes into breast milk in small amounts. Consult your doctor before breast-feeding.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Some products that may interact with this drug include: azole antifungals (e.g., fluconazole, itraconazole).
Some drugs may cause hormonal birth control to work less well by decreasing the amount of birth control hormones in your body. This effect can result in pregnancy. Examples include griseofulvin, modafinil, rifamycins (such as rifampin, rifabutin), St. John's wort, drugs used to treat seizures (such as barbiturates, carbamazepine, felbamate, phenytoin, primidone, topiramate), HIV drugs (such as nelfinavir, nevirapine, ritonavir), among others.
Tell your doctor when you start any new drug, and discuss if you should use additional reliable birth control. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.
This medication can affect the results of certain lab tests (e.g., sex-hormone-binding globulin, thyroid). Make sure laboratory personnel and all your doctors know you use this medication.
This medication may be harmful if swallowed. Overdose may occur if more than 1 rod is placed or the old rod is not removed when a new rod is placed. If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Keep all laboratory and medical appointments. You should have regular complete physical exams including blood pressure, breast exam, pelvic exam, and screening for cervical cancer (Pap smear). Follow your doctor's instructions for examining your own breasts, and report any lumps immediately. Consult your doctor for more details.
The rod must be removed or replaced after 3 years.
Store at room temperature away from light and moisture until insertion. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised June 2014. Copyright(c) 2014 First Databank, Inc.
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